TUBING, DIALYSATE (AND CONNECTOR)

K022068 · Molded Products, Inc. · FID · Sep 23, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022068
• Device Name: TUBING, DIALYSATE (AND CONNECTOR)
• Applicant: Molded Products, Inc.
• Product Code: FID · Gastroenterology, Urology
• Decision Date: Sep 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Indications for Use

The MPC-740 is a Male to Male Dialysate Connection Connector. It may be used to connect the MPC-725 to the Dialysis machine Dialysate Line in order to extend the length of the Dialysate Tubing. May also be used as a recirculation connector; connecting both dialysis machine Dialysate lines together. The MPC-725 is a Female to Female Dialysate Connection Connector. When connected to the MPC-740 (which has been connected to the dialysis machines' dialysate line) this line may be used to extend the length of the Dialysis Machine Dialysate Line. The MPC-725 may also be used to connect one Dialyzer Port to another Dialyzer Port.

Device Story

Dialysate Tubing with Connectors (MPC-725 and MPC-740) are mechanical accessories for hemodialysis systems. MPC-740 is a male-to-male connector; MPC-725 is a female-to-female connector. Devices function by physically coupling dialysate lines to extend tubing length or by connecting dialyzer ports. Used in clinical dialysis settings by trained healthcare professionals. No electronic or software components. Benefit includes flexibility in configuring hemodialysis circuit connections.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical connectors for hemodialysis tubing. No energy source, software, or electronic components. Materials and sterilization methods are standard for hemodialysis accessories.

Indications for Use

Indicated for use in hemodialysis procedures to connect or extend dialysate tubing lines and connect dialyzer ports.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 2 3 2002

Ms. Elise Johnston Quality Assurance MOLDED PRODUCTS, Inc. 601 Durant Street HARLAN IA 51537

Re: K022068

Trade/Device Name: Dialysate Tubing with Connectors MPC-725 and MPC-740 Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FID Dated: June 20, 2002 Received: June 25, 2002

Dear Ms. Johnston:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) NUMBER (IF KNOWN):

Dialysate Tubing with Connectors DEVICE NAME:

INDICATIONS FOR USE:

#### MPC-740

The MPC-740 is a Male to Male Dialysate Connection Connector. It may be used to connect the MPC-725 to the Dialysis machine Dialysate Line in order to extend the length of the Dialysate Tubing. May also be used as a recirculation connector; connecting both dialysis machine Dialysate lines together.

### MPC-725

The MPC-725 is a Female to Female Dialysate Connection Connector. When connected to the MPC-740 (which has been connected to the dialysis machines' dialysate line) this line may be used to extend the length of the Dialysis Machine Dialysate Line. The MPC-725 may also be used to connect one Dialyzer Port to another Dialyzer Port.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display:inline-block;">✓</div> | OR | Over-The-Counter-Use |
|----------------------|--------------------------------------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

| | Nancy C <hr/> (Division Sign Off) |
|---------------|--------------------------------------|
| | Division of Reproductive, Abdominal, |
| | and Radiological Devices |
| 510(k) Number | K022068 <hr/> |